Panels › Ophthalmic › Product code MVN · Class 2
Lens, Contact, (Disposable)
Regulation 886.5925
1510(k)s in 12 months (26 all time)
1recalls in 12 months (17 all time)
14recalls that name a 510(k)
Top companies in MVN
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperVision, Inc. | 2 | 12 |
| Ciba Vision Corporation | 6 | 0 |
| Bausch & Lomb | 4 | 0 |
| Johnson & Johnson Vision Care, Inc. | 1 | 3 |
| Alcon Laboratories, Inc. | 2 | 0 |
| Innova Vision, Inc. | 2 | 0 |
| Sauflon Pharmaceuticals, Ltd. | 2 | 0 |
| Yung Sheng Optical Co., Ltd. | 2 | 0 |
| 1-800 Contacts Inc. | 0 | 1 |
| Ciba-Geigy Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | CooperVision, Inc. Brand Name: Pearle Vision 1 day
Product Name: (somofilcon A) Contact Lens
Model/Catalog Number: Pearle Vision 1 day Open, Classified |
MVN | K130331 |
| Sep 19, 2025 | CooperVision, Inc. Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Open, Classified |
MVN | K131378 K190965 +1 |
| Sep 19, 2025 | CooperVision, Inc. Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wea Open, Classified |
MVN | K131378 K190965 +1 |
| Sep 19, 2025 | CooperVision, Inc. MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blist Open, Classified |
MVN | K131378 K190965 +1 |
| Mar 26, 2025 | CooperVision, Inc. Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voy Open, Classified |
MVN | K131378 K190965 +1 |
| Jul 5, 2024 | Ontact Inc 24K Premium Lense, Distributed by Updream Inc. Open, Classified |
MVN | None listed |
| Feb 21, 2018 | CooperVision Inc. 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indic Terminated |
MVN | K130331 |
| Feb 21, 2018 | CooperVision Inc. 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indic Terminated |
MVN | K130331 |
| Feb 21, 2018 | CooperVision Inc. clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is Terminated |
MVN | K130331 |
| Feb 21, 2018 | CooperVision Inc. clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV b Terminated |
MVN | K130331 |
| Dec 18, 2017 | Johnson & Johnson Vision Care, Inc. ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90. Terminated |
MVN | K042275 |
| Oct 19, 2017 | Johnson & Johnson Vision Care, Inc. 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses Terminated |
MVN | K051900 |
| Dec 19, 2013 | CooperVision Inc. ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 Terminated |
MVN | K091339 |
| Dec 19, 2013 | CooperVision Inc. Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA
daily us Terminated |
MVN | K061948 |
| Jan 12, 2012 | Johnson & Johnson Vision Care, Inc. Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA*** Terminated |
MVN | K051900 |
| Nov 9, 2009 | CooperVision Inc. ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each len Terminated |
MVN | None listed |
| Nov 3, 2004 | 1-800 Contacts Inc. Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE Terminated |
MVN | None listed |
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